- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06559917
Effectiveness on Family Cohesion and Happiness of Using Social Media to Enhance Happiness Accounts for Late-Stage Cancer Patients and Their Families
August 14, 2024 updated by: YANG WEN-CHI
The study period is from September 1, 2024, to December 31, 2025.
The subjects are cancer patients from the medical center of this hospital.
A block randomization will be used to assign 100 patients to the experimental group and 100 patients to the control group, totaling 200 patients.
During the study process, questionnaires and medical records of the subjects will be collected.
The experimental group will receive the social media "Happiness Ledger" intervention, while the control group will receive routine treatment.
Questionnaires will be collected from both groups before and after the intervention.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
-
Inclusion Criteria for Advanced Cancer Patients:
- Patients diagnosed with stage III or IV cancer by a specialist physician.
- Patients who agree to participate in the study after being informed about the research.
- Patients who are conscious and able to communicate in Mandarin or Taiwanese.
- Patients aged 20 years or older.
- Patients with no history of mental illness.
Inclusion Criteria for Family Members:
- The primary caregiver of a patient diagnosed with stage III or IV cancer by a specialist physician.
- The primary caregiver who has a blood, marital, or cohabitation relationship with the patient.
- Family members who agree to participate in the study after being informed about the research.
- Family members who are conscious and able to communicate in Mandarin or Taiwanese.
- Family members aged 20 years or older.
- Family members with no history of mental illness.
Exclusion Criteria:
-
Exclusion Criteria for Advanced Cancer Patients:
- Patients in the experimental group and control group who reside in the same ward.
- Patients who share a ward with subjects already included in the study.
- Patients involved in ongoing medical disputes.
- Patients who cannot understand the study explanation due to language or cognitive impairments.
- Patients with a life expectancy shorter than the planned study duration.
Exclusion Criteria for Family Members:
- Family members who do not have direct living or caregiving contact with the patient.
- Family members who cannot visit the patient regularly or participate in the study.
- Family members who cannot understand the study explanation due to language or cognitive impairments.
- Family members with significant visual or hearing impairments who do not use assistive devices and cannot resolve communication issues.
- Family members who cannot make independent decisions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Upon admission to the cancer-related ward, after explaining the purpose and process of the study, patients who agree to participate in the study will complete the first questionnaire before the intervention with the social media "Happiness Ledger".
The family members will have one week to organize photos, after which the patients will share the meaning of the photos.
The process will be recorded by the researcher and will last approximately 40 to 60 minutes.
Afterward, the researcher will create a video of about three minutes using the photos and ask the participating family members to assist in uploading the photos to the family LINE group as feedback to the research subjects.
The patients will then complete the second questionnaire.
|
After consenting, they will complete the first questionnaire before receiving the "Happiness Ledger" intervention via social media.
Family members will have one week to organize photos, after which patients will share the meaning of the photos.
This process will be recorded by the researcher and will last approximately 40 to 60 minutes.
The researcher will then create a three-minute video using the photos, and the participating family members will assist in uploading the photos to the family LINE group as feedback to the subjects.
The second questionnaire will then be completed.
|
|
No Intervention: Control Group
After explaining the purpose and process of the study to the patients and their family members on the day of admission, and obtaining their consent to participate in the study, they will complete the first questionnaire.
One week later, they will complete the second questionnaire.
After the entire study is completed, the control group will receive the same social media "Happiness Ledger" intervention as the experimental group.
Data collection will be conducted for both groups before and after the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family Cohesion
Time Frame: Baseline (pre-intervention) and 1 week after intervention
|
This study uses the Family Adaptability and Cohesion Evaluation Scale (FACES II) developed by Olson et al. (1979), which consists of 30 items to measure the family cohesion of patients and their families .
|
Baseline (pre-intervention) and 1 week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Happiness
Time Frame: Baseline and 1 week
|
This study uses the Subjective Happiness Scale (SHS) created by Lyubomirsky & Lepper (1999), which consists of 4 items to measure the happiness of patients and their families."
|
Baseline and 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
August 6, 2024
First Submitted That Met QC Criteria
August 14, 2024
First Posted (Actual)
August 19, 2024
Study Record Updates
Last Update Posted (Actual)
August 19, 2024
Last Update Submitted That Met QC Criteria
August 14, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- A202405117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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